Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea (TVLOD)

Soroka University Medical Center

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01319058

sor495810ctil

Details and patient eligibility

About

Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.

the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.

Full description

Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.

the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.

In the study three approaches are prospectively compared:

1. Tonsillectomy - using electrocautery resecting all tonsillar tissue.
2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.
3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.

All patients will be randomized to one of three arms. Each arm will include 25 children.

All children will have a preoperative and postoperative sleep study. Questioners assessing pain, amount of medication used to control pain and sleep disturbance during the first 7 days after surgery will be filled by the child caretaker.

Blood will be drawn immediately before surgery and 18-24 hours after surgery. The following blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1 beta,TNF alpha, IL6, IL2.

If the study will show objectively and subjectively that partial resection of the tonsil compared to complete tonsillectomy is less painful and has less postoperative inflammation.

Enrollment: 88 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids

Exclusion criteria

Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 3 patient groups

Electrocautery tonsillectomy

Active Comparator group

Description:

Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea

Treatment:

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Debrider tonsillotomy

Active Comparator group

Description:

Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.

Treatment:

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Laser tonsillotomy

Active Comparator group

Description:

Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.

Treatment:

Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy